BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENFIT PU FEEDING TUBE ORANGE 5FR 90CM

    MDR report key: 18331541 · Received December 14, 2023

    Report

    Report Number
    3011270181-2023-00139
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Report Date
    February 16, 2024
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    UDI-DI
    00350770000657
    PMA / PMN Number
    K082238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: A CONNECTOR WAS RECEIVED ALONG WITH FIRST SAMPLE FROM REPORT 3011270181-2023-00138. THIS INCOMPLETE DEVICE WAS COMPRISED OF A NEOMED CLEANING BRUSH WITH AN ORANGE CONNECTOR INSIDE. THE CONNECTOR APPEARANCE WAS CONSISTENT WITH A NEOMED NG TUBE. HOWEVER, THERE IS NO STOCK CODE IDENTIFICATION ON THESE COMPONENTS. THE TUBING PORTION WAS NOT RECEIVED. THE DISTAL END OF THE ORANGE CONNECTOR WAS EXAMINED UNDER MAGNIFICATION. THERE WAS A REMNANT OF TUBING VISIBLE INSIDE THE DISTAL END. THE EDGE OF THE TUBING APPEARS JAGGED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 16-FEB-2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(6). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : INCOMPLETE DEVICE RETURNED.

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 14-DEC-2023 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 C.F.R. 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3011270181-2023-00138 FOR THE FIRST EVENT. IT WAS REPORTED THE TUBE BROKE WHILE INSIDE THE PATIENT. A NEW DEVICE WAS PLACED. ADDITIONAL INFORMATION RECEIVED 28-NOV-2023 STATED THE PATIENT WAS A REGIONAL NEONATAL INTENSIVE CARE UNIT (RNICU) PATIENT AND THE EVENT OCCURRED A COUPLE OF DAYS AFTER THE DEVICE WAS INSERTED. THE PATIENT IS STABLE, NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098954 ENFIT PU FEEDING TUBE ORANGE 5FR 90CM DH NASOGASTRIC (NG) FEEDING TUBES (NEOMED AND NEOCONNECT) FPD AVANOS MEDICAL INC. FTL5.0P-NC UNKNOWN 00350770000657

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown